What describes the stopping rules or discontinuation criteria for the trial?

• A. Stopping rules for individual subjects
• B. Discontinuation criteria for parts of the trial
• C. Stopping rules for the entire trial
• D. Stopping rules for individual subjects, parts of the trial and the entire trial

Answer: (D)

Stopping rules define when trial activities must be halted to protect participant safety and the integrity of the study. They can apply at multiple levels: to individual participants (when a subject should discontinue due to adverse events, withdrawal of consent, or major protocol violations), to parts of the trial (a specific dose group, arm, or cohort is stopped while the rest continues), and to the entire trial (the whole study is stopped due to safety concerns, futility, or other predefined criteria). In GCP, these criteria are planned and documented in the protocol (and often overseen by a DSMB/DSMC) so that decisions to halt are predefined and ethically justified. Therefore, stopping rules for both individuals, parts of the trial, and the entire trial best describe how and when a study should stop. The other options describe only one level each and thus do not capture the full scope of stopping criteria.